More Ways to Short-Circuit the FDA Guidelines

Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP

Mar 1, 2012

The FDA has proposed guidelines for approving the first lower-cost copies of biologic drugs derived from living cells. All that would be required are laboratory and clinical studies showing the generic versions are "highly similar" to the originals. This involves what are known as "biosimilar" drugs. They treat cancer, arthritis and other diseases. Unlike stable generic pharmaceutical drugs that are often in pills and capsules, biologics are made from biological material and injected. Companies will have to prove similar protein mapping. While we applaud any measure to treat a disease more efficiently and economically, we note that there have been plenty of problems with injuries caused by generic pharmaceutical drugs, most notably Reglan (metoclopramide), and we are concerned that this may occur with biologics when approval gets streamlined.

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